BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2251198 · Received September 16, 2011

    Report

    Report Number
    2024168-2011-06357
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    May 26, 2011
    Report Date
    August 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD ON THE HUB, SHAFT, BALLOON AND STENT IMPLANT AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST ON THE SHAFT AND IN THE INFLATION LUMEN. THIS IS CONSISTENT WITH HANDLING, PREPARATION, AND SUGGESTS THE SDS WAS ADVANCED INTO THE BODY. THE UNDAMAGED STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS. THE TIP LENGTH AND STENT IMPLANT OUTER DIAMETERS MET MANUFACTURING CRITERIA. THERE WAS A KINK AND A BEND IN THE HYPOTUBE. THIS DAMAGE WAS NOT OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND THUS, MAY HAVE OCCURRED DURING OR AFTER THE PROCEDURAL ATTEMPTS TO CROSS THE LESION OR POSSIBLY AS A RESULT OF PACKAGING AND SHIPMENT BACK TO ABBOTT VASCULAR FOR ANALYSIS. THE HYPOTUBE HAD SEPARATED 15.5 CENTIMETERS DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED AS IF KINKED PRIOR TO SEPARATING. THE HYPOTUBE JACKET WAS STRETCHED AND SEPARATED AT THE SAME LOCATION. THIS TYPE OF FAILURE IS OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A BEND. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE SDS MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. SINCE THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE SDS PRIOR TO THE PROCEDURE, THIS MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED SHAFT SEPARATION. THE SHAFT MOST LIKELY KINKED DURING THE ATTEMPT TO CROSS AND FURTHER MANIPULATION OF THE CATHETER WOULD HAVE CONTRIBUTED TO THE SHAFT SEPARATING. A REVIEW OF THE LOT HISTORY RECORD FOR THE REPORTED LOT WAS PERFORMED AND DID NOT REVEAL ANY ASSOCIATED NONCONFORMING MATERIAL RECORDS WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A QUERY THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT WAS PERFORMED AND THERE ARE NO OTHER INCIDENTS REPORTED FOR SHAFT SEPARATION. THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED FOR KINKS DURING THE MANUFACTURING PROCESS, INCLUDING A FINAL INSPECTION OF THE PRODUCT BEFORE BEING INSERTED INTO THE DISPENSER COIL. ADDITIONALLY, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREDILATATION WAS PERFORMED IN THE CALCIFIED AND TORTUOUS LEFT CIRCUMFLEX ARTERY; HOWEVER, THE XIENCE V FAILED TO CROSS THE LESION. THE EXTERNAL PART (PROXIMAL SHAFT) SEPARATED INTO TWO PIECES. THE XIENCE V STENT WAS NOT IMPLANTED. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY ONLY WITH A GOOD RESULT. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1012841

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR